food and drug administration fda

A Hepatitis A outbreak across five states traced to an organic frozen berry mix sold at Costco left thirty people have been infected, and nine of them hospitalized.

And health officials are bracing for more cases if cafes and restaurants that bought the frozen blend used it to make smoothies, frozen bar drinks and other desserts for customers.

The Food and Drug Administration (FDA) and federal Centers for Disease Control and Prevention (CDC) have linked the reported illnesses to Townsend Farms Organic Anti-Oxidant Blend, a mix of berries and pomegranate seeds produced by Townsend Farms in Oregon.

The first victim got sick on April 29 with the most recent case reported on May 17, although USA Todayreports more are expected.

The victims, aged between 25 and 71 years old, live in Colorado, New Mexico, Nevada, Arizona and California.

About 11 of 17 of those infected said they bought the berry mix at Costco, according to CNN.

A Costco spokesman saidthat the company has removed the product from stores and is attempting to contact members who purchased the product in recent months.

A Hepatitis A outbreak across five states traced to an organic frozen berry mix sold at Costco left thirty people have been infected, and nine of them hospitalized

Townsend Farms lawyer Bill Gaar said the frozen organic blend bag included pomegranate seeds sourced from Turkey, and were only used in the product associated with the outbreak.

“We do have very good records, we know where the (pomegranate seeds) came from, we’re looking into who the broker is and we’re sourcing it back up the food chain to get to it,” Bill Gaar said.

He said Townsend Farms believes Costco is the only customer who bought the product but are checking to see if any other retailers also sold it.

CNN reports state health departments, the FDA and the CDC are investigating, after notifying Townsend Farms on Thursday and sending investigators to the Fairview farm.

Hepatitis A is a highly infectious disease which inflames the liver, and is usually transmitted via contaminated food or water, or by someone who is infected.

The Mayo Clinicwebsite states: “Mild cases of Hepatitis A don’t require treatment, and most people who are infected recover completely with no permanent liver damage.”

However, the World Health Organization (WHO) says severe infection can lead to liver failure and death, with about 1.4 million cases of Hepatitis A annually worldwide.

Cellulaze, a pioneering invasive cosmetic treatment which targets the dreaded appearance of quilted, pitted fat, has hit the market causing a media storm.

Affecting more than 8 out of 10 women, cellulite is considered one of the curses of female gender, but Cellulaze is considered one of the best weapons to banish orange-peel thighs.

Cellulite occurs when the strands that connect the layers of tissue and the fat below the skin (fibrous septae) gradually harden and contract, while the fat between stays the same and protrudes out in a lumpy fashion.

Diet, exercise, creams and massage do help, but chronic sufferers are constantly on the lookout for a long-term solution.

The Sunday Times Stylemagazine has reported that new laser cellulite treatment Cellulaze claims to melt the fat and then break down the fibres anchoring the tiny fat pockets, thus banishing the appearance of cellulite.

It is the first scientifically validated laser cellulite treatment to win the approval of the Food and Drug Administration (FDA), which accepted the results of Cellulaze’s year-long trial last January.

The study was conducted in the University of Medicine and Dentistry of New Jersey and monitored a group of women with an average age of 47.

It showed that just one Cellulaze treatment prevented the return of cellulite for at least a year. There are even claims that the earliest patients have remained cellulite-free for three years.

The treatment, which costs upwards of $4,000, takes one to two hours and involves a local anaesthetic and mild sedation, followed by the insertion of a laser rod, like a fine knitting needle, just below the surface of the skin through a series of tiny cuts, reported the Sunday Times.

Cellulaze is the first scientifically validated laser cellulite treatment approved by FDA

Laser beams then transmit energy sideways from the rod to smooth out lumpy fat cells and heat dermal tissue. The method promotes skin thickening and tightening, resulting in tighter, smoother skin. The laser directly targets the structure of cellulite.

As well as destroying the lumps, it stimulates collagen production just below the surface, and, in most cases, gives a smoother result than anything previously achieved by other anti-cellulite treatments.

The Cellulaze laser fiber claims to level out bumps of fat, treat dimples by releasing the fibrous bands that pull down on the skin, and stimulate collagen production to increase skin’s depth and elasticity for a smoother look.

Liquefied fat is then pressed out.

Hassan Shaaban, a consultant plastic surgeon at the Sthetix clinic in Liverpool, was the British pioneer, and has now become the principal specialist training other doctors from across Europe in the technique.

He warns that not every patient will benefit.

“We classify cellulite severity from one to four,” he says.

“This treatment works best on stages two and three. In other words, women with serious cellulite will first have to lose fat by other methods.”

The cosmetic surgeon Angelica Kavouni, of the Cadogan Clinic in London, underwent the training last December and has already treated 15 women. \

“I am cautiously optimistic that it works, but I think most patients will also have to make lifestyle changes such as diet and more exercise to maintain the results,” she told the Sunday Times.

The Food and Drug Administration (FDA) in the US has approved the “morning-after” pill without a prescription for women aged 15 and over.

Proof-of-age will be required to purchase the drug, Plan B. The decision comes a month after a judge ordered the drug to be made available to girls of all childbearing ages.

The FDA said its decision was not a response to the court ruling.

Reproductive rights groups approved the FDA move but called for fuller access.

On Tuesday, the FDA said its decision was in response to an amended marketing plan from the drug’s maker, Teva Pharmaceuticals, to sell Plan B without a prescription to women 15 and older.

But the move comes days before the deadline to comply with a New York district judge’s order to make the drug available over the counter to girls of all childbearing ages.

The FDA has approved the morning-after pill Plan B without a prescription for women aged 15 and over

The judge criticized the Obama administration for imposing an age-17 limit.

In 2011, the FDA said it had concluded the “morning after” pill could be safely used by girls of child-bearing age.

But in an unprecedented move, Health and Human Services Secretary Kathleen Sebelius overruled the agency.

Kathleen Sebelius said there was not enough evidence from all potential ages to support removing over-the-counter restrictions.

The Obama administration was accused of bowing to pressure from social conservatives.

The reproductive rights group that brought the lawsuit said on Tuesday it will continue its legal fight if need be.

Lowering the age limit “may reduce delays for some young women but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification”, said Nancy Northup, president of the Center for Reproductive Rights.

Airplane food has long been the butt of jokes for being bland, unimaginative and generally unappetizing, but now there is evidence to suggest that the meals served by airlines are not just lackluster, but they might actually make passengers sick.

Inspections of airlines and outside caterers conducted by the Food and Drug Administration (FDA) have revealed facilities crawling with mice, roaches and ants, and food preparation areas swarming with flies.

According FDA health violation records obtained by ABC’s 20/20, over the past four years, there have been more than 1,500 violations in the airline food industry. The federal agency said that “significant” problems were found at a much higher rate than in other industry it inspects.

The FDA reported evidence of mice on Delta Airlines planes. In response, the carrier released a statement calling the findings an “isolated incident’. The statement goes on to say that the inspections, some of them dating back to 2009, were conducted in lavatory service trucks and aircraft potable water, and the problems uncovered by the agency have since been addressed.

Insects were also found inside the facilities of the industry giant LSG Sky Chefs which provides food for several airlines. According to the FDA records, inspectors have observed ants crawling over discarded food, flies both dead and alive, and roaches through the company’s food preparation facilities.

The company issued a statement saying that after being issued a warning letter by the FDA regarding food safety violations, LSG immediately addressed the problems to ensure complete compliance.

The catering service added that “food safety and quality are out number one priority”.

Inspections of airlines and outside caterers conducted by the FDA have revealed facilities crawling with mice, roaches and ants, and food preparation areas swarming with flies

Another company cited in the FDA records is airline food provider Gate Gourmet, whose facilities were said to be crawling with gnats “too numerous to count”, as well as roaches.

Besides critters in food facilities, FDA reports indicate that at several companies inspectors found other gross violations such as filthy cooking areas, old and moldy products and employees not washing their hands. For example, at the Gate Gourmet facilities, food was left outside refrigerators and utensils were stacked on dirty racks.

This is not the first time that airplane food safety concerns have been raised in the media.

In 2010, USA Today obtained FDA records painting a similarly unsettling picture: food being stored at improper temperatures, dirty equipment and signs of improper pest control in the shape of cockroaches, flies and mice.

Catering companies like LSG and others told ABC that they take food sanitation very seriously and make sure to address problems at once. They also said that they serve tens of millions of meals a year both at home and abroad without incident.

Passengers who spend several hundred dollars extra to fly first or business class in hopes of getting not only better plane accommodations, but also a superior meal, may find themselves disappointed.

According to Roy Costa, a food-industry consultant and former health inspector, a filet mignon presented on a china platter may suffer from the same problems as the grey mystery meat patty served on a plastic trey in coach.

Fungal meningitis outbreak death toll has risen to seven in U.S.

The disease has been linked to spinal steroid injections, sparking fear as new cases have been reported in nine states.

The potential scope of the meningitis outbreak, that has sickened 64 people, widened dramatically as health officials warned that hundreds, perhaps thousands, of patients who received steroid back injections in 23 states could be at risk.

The outbreak of the disease, known as Aspergillus meningitis, is caused by a fungus found in a spinal steroid injections, a fairly common treatment used to relieve back pain, according to the Food and Drug Administration (FDA).

The latest fatalities were reported in Michigan on Saturday, though the Michigan Department of Community Health said they would not provide more information on the two deaths until after the weekend.

The fifth victim, Diana Reed, died on Wednesday afternoon at St Thomas Hospital in Nashville, Tennessee, surrounded by family members.

Diana Reed, 56, is one of thousands of patients recently treated in Tennessee hospitals for back pain with a steroid epidural – a fairly typical treatment. But since then a tainted batch of steroids released across the U.S. has been linked to dozens of cases of fungal meningitis.

The injectable steroids responsible for Diana Reed’s death were produced by New England Compounding Center, a specialized pharmacy in Framingham, Massachusetts. The company has shut down operations and said it is working with regulators to identify the source of the infection.

It is not clear how many patients received tainted injections, or even whether everyone who got one will get sick.

So far, 64 people in nine states – Tennessee, Virginia, Maryland, Florida, North Carolina, Indiana, Michigan, Minnesota and Ohio – have contracted fungal meningitis, and five have died, according to the Centers for Disease Control and Prevention (CDC).

In an alarming indication that the outbreak could get a lot bigger, Massachusetts health officials said the pharmacy involved, the New England Compounding Center of Framingham, has recalled three lots consisting of a total of 17,676 single-dose vials of the steroid, preservative-free methylprednisolone acetate.

An unknown number of those vials reached 75 clinics and other facilities in 23 states between July and September, federal health officials said. Several hundred of the vials, maybe more, have been returned unused, one Massachusetts official said.

However, many other vials were used. At one clinic in Evansville, Indiana, more than 500 patients got shots from the suspect lots, officials said. At two clinics in Tennessee, more than 900 patients received them.

The incubation period before symptoms appear is 28 days, and is almost certain more cases will be reported say health officials, who are now calling this a national health crisis.

Unlike the more common viral and bacterial meningitis, fungal meningitis is not contagious. It is an inflammation of the brain and spinal cord.

Symptoms include a severe headache, nausea, fever, and dizziness.

The first patients identified in Tennessee experienced slurred speech, and difficulty walking and urinating.

The pharmacy voluntarily recalled three lots of the steroid Methylprednisolone Acetate on September 26 according to the FDA. The drug is primarily used to relieve back pain.

The drug was administered to patients in their late 40s to early 80s.

Tennessee’s S. Thomas Hospital, ground zero for the outbreak with a suspected 15 cases as of Wednesday with two in critical condition, reported having 2,000 vials of the steroid in stock before the threat was discovered.

“Some are doing well and improving. Some are very ill – very, very seriously ill and may die,” Tennessee health official Dr. David Reagan said.

In Tennessee alone roughly 1,000 people were administered the steroid.

The link between the injections and the meningitis was discovered by Tennessee physician April Pettit, who found the initial cases were all people who’d recently received an epidural.

Officials are still investigating how the steroid resulted in fungal meningitis.

New England Compounding Center released a statement promising to work with heath authorities to discover what happened. But company president and licensed pharmacist Barry J. Cadden has otherwise dodged interview requests and the company web site is down.

An archived version of the site notes the company is licensed to distribute drugs in every U.S. state.

New England Compounding Center is among the approximately 3,000 U.S. compounding pharmacies specializing in blending, liquefying, or combining medicines customized for patients unable to swallow tablets, require specific dosages, or who have allergies.

Such companies are regulated by the state boards of pharmacy that license them rather than facing the broader regulations traditional drug companies deal with.

The pharmacy has produced questionable products before. In 2006, New England Compounding Center was one of four companies ordered by the Food and Drug Administration to cease producing a topical anesthetic cream that was found to cause “grave reactions including seizures and irregular heartbeats”.

The cream was the cause of two deaths, neither tied directly to New England Compounding Center.

That same year the company was also cited for multiple violations of federal laws and regulations based on a 2004 review of its offices. They were charged with misbranding drugs prescribed for eye treatment, misbranding an anesthetic drug and failing to provide adequate directions for its use, and promoting the use of a cancer drug for an unapproved purpose.

An FDA warning letter admonished the company that it was “distributing an unapproved drug in violation” of federal regulations.

In 2010 the company was sued by an Illinois firm that alleged New England Compounding Center illegally hacked its database violating the federal computer fraud and abuse act. The case was eventually settled.

STATE-BY-STATE BREAKDOWN

Tennessee: The initial outbreak site with a suspected 16 cases, two of whom are in critical condition. Three others have already died.

North Carolina: The second state to report infection with one case found at an unidentified clinic.

Florida: Only two cases have been reported but health officials fear more may come forward.

Virginia: One person has died from fungal meningitis and three more cases are still being treated.

Maryland: Seven medical clinics in Maryland pulled their stock of a questionable steroid after one person died and two more cases were reported.

Indiana: At least five people in Indiana are sick with fungal meningitis, with no fatalities yet reported.

Michigan: There are at least eight confirmed cases of meningitis in Michigan, including two deaths.

Minnesota: Fungal meningitis has been diagnosed in two women hospitalized in Minnesota.

Ohio: Health officials reported Saturday of a 65-year-old man being treated for the meningitis after receiving the steroid.

An outbreak of rare fungal meningitis in the US has now affected 47 people in seven states, Center for Disease Control (DCD) officials say.

Doctors at about 75 medical clinics are being warned to alert patients who received suspect steroid injections.

Five people have died from the illness, which the CDC has linked to products from a Massachusetts-based pharmacy firm.

Officials say they found contamination in a sealed steroid vial at the New England Compounding Center.

The firm recalled the steroid doses and has since shut down operations, but the vials have already been shipped to 23 states.

Meningitis is an inflammation of the lining of the brain and spinal cord. Symptoms include severe headache, nausea, and fever as well as slurred speech and difficulty walking.

The fungal meningitis causing concern in the US is not infectious, the CDC says.

Confirming that 47 people were now affected – an increase of 12 in the space of 24 hours, the CDC said new cases were reported for the first time in Michigan.

In Tennessee, which has the majority of the cases, a total of 29 people have now fallen ill. There were six cases in Virginia, three in Indiana Indiana, two each in Maryland and Florida and one in North Carolina, the CDC said.

It is not yet clear how many patients may have been exposed to any contamination, and fungal meningitis can have a lengthy incubation period.

A briefing by the CDC and the Food and Drug Administration (FDA) on Thursday said a fungus linked to the steroid medication had been identified in tests of five patients.

“Out of an abundance of caution, we advise all health care practitioners not to use any product” from the company, said Ilisa Bernstein, director of compliance for the FDA’s Center for Drug Evaluation and Research.

New England Compounding Center is a type of pharmacy that mixes ingredients for customized medicines. The steroid in question was three lots of methylprednisolone acetate from the firm.

On Friday, the CDC listed about 75 clinics and medical centres that received the suspected lots, and told doctors to immediately contact patients who have had an injection.

Tests are under way to confirm if the contamination is the same fungus blamed in the outbreak. The disease cannot be passed from person to person.

Three people have died in Tennessee, with one death in Virginia and one in Maryland, reports say.

An appeals court in Washington has ruled that US government cannot force tobacco firms to put large graphic health warnings on cigarette packages.

It said the government’s plan undermined free speech in America.

The Food and Drug Administration (FDA) had wanted to put nine pictures of dead and diseased smokers to convey the dangers of cigarettes.

However, tobacco companies had argued that the images went beyond factual information and into anti-smoking advocacy.

The ruling comes as a number of other countries have ordered similar pictures to be placed on all cigarette packets.

An appeals court in Washington has ruled that US government cannot force tobacco firms to put large graphic health warnings on cigarette packages

Australia has gone a step further, banning even tobacco company logos from the cartons.

The US Court of Appeals affirmed an earlier lower court ruling in a 2-1 decision.

It said the case raised “novel questions about the scope of the government’s authority to force the manufacturer of a product to go beyond making purely factual and accurate commercial disclosures and undermine its own economic interest”.

The court said that in this case it was “by making every single pack of cigarettes in the country a mini billboard for the government’s anti-smoking message”.

It added that the FDA “has not provided a shred of evidence” that the images would directly advance its policy aimed at reducing the number of smokers in America.

The verdict was welcomed by tobacco companies, with Lorrilard Tobacco’s describing it as “a significant vindication of First Amendment principles”.

The FDA has so far made no public comment on whether it intends to appeal against the ruling in the US Supreme Court.

US health regulators have approved weight-loss pill Belviq, marking the first new drug treatment in 13 years.

Belviq (lorcaserin hydrochloride), made by Arena Pharmaceutical, can be used by obese or overweight adults with at least one condition.

The drug achieved only modest results in clinical studies, helping people lose on average about 5% of their body weight.

Belviq was rejected in 2010 because of concerns over tumors that developed in animals tested with the drug.

After San Diego-based Arena resubmitted its application with more data, the US Food and Drug Administration (FDA) found little risk of tumors in humans using the drug.

FDA approved weight-loss pill Belviq, marking the first new drug treatment in 13 years

The medication is expected to launch in 2013.

Belviq is designed to block appetite signals in the brain, making patients feel fuller with smaller amounts of food.

Belviq is a serotonin 2C receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition, (e.g., hypertension, dyslipidemia, type 2 diabetes).

The FDA warned that Belviq is not for women who are pregnant or nursing.

With US obesity rates approaching 35% in adults and associated healthcare costs on the rise, many doctors have urged health regulators to give the green light to new weight-loss treatments.

But the agency has set high standards for such medication after safety problems with previously popular weight-loss drugs.

The so-called fen-phen combination had to be pulled from the market in 1997 after being linked to heart valve damage.

In a statement, the FDA said Belviq did not appear to carry the same risks.

However, known side effects of Belviq do include depression, migraine and memory lapses.

The FDA-approved label says the drug should not be used for more than 12 weeks if a 5% weight loss does not occur.

Arena will be required to conduct six studies after marketing the drug, including a study on the drug’s effect on long-term heart health.

US Antiviral Drugs Advisory Committee, which advises the FDA, has for the first time backed a drug to prevent HIV infection in healthy people.

The panel of health experts recommended US regulators approve daily pill Truvada for use by people considered at high risk of contracting the AIDS virus.

The US Food and Drug Administration (FDA) is not required to follow the panel’s advice, but it usually does.

Some health workers and groups active in the HIV community have opposed the approval of the drug.

However, the move could prove to be a new milestone in the fight against HIV/AIDS.

The Antiviral Drugs Advisory Committee recommended US regulators approve Truvada for use by people considered at high risk of contracting the AIDS virus

Truvada is already approved by the FDA for people who are HIV-positive, and is taken along with existing anti-retroviral drugs.

Studies from 2010 showed that Truvada, made by California-based Gilead Sciences, reduced the risk of HIV in healthy gay men – and among HIV-negative heterosexual partners of people who are HIV-positive – by between 44% and 73%.

The Antiviral Drugs Advisory Committee voted 19-3 in favor of prescribing the drug to the highest risk group – non-infected men who have sex with multiple male partners.

They also approved it, by majority votes, for uninfected people with HIV-positive partners and for other groups considered at risk of acquiring HIV through sexual activity.

The votes followed an 11-hour meeting of the panel in Silver Spring, Maryland, and a lengthy public comments session.

Opposition to the prospect of approving the drug is based on concerns that users could gain a false sense of security, and fears of a drug-resistant strain of HIV.

There is also concern that the high cost of Truvada could divert limited funding from more cost-effective options.

“We need to slow down. I care too much about my community not to speak my concerns,” said Joey Terrill, of the AIDS Healthcare Foundation, which campaigned against the drug’s approval.

Nurse Karen Haughey told the panel: “Truvada needs to be taken every day, 100% of the time, and my experience as a registered nurse tells me that won’t happen.

“In my eight years, not one patient that I’ve cared for has been 100% adherent.”

But others welcomed the panel’s recommendation.

“This brings us closer to a watershed for global HIV prevention efforts,” said Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition, after the vote.

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